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Regulatory Actions for Year 1991

Year Agency Title CASRN
1991 FDA
Topical Acne Drug Products for Over-The Counter Human Use; Amendment of Tentative Final Monograph

Proposed Rule: Amendment to final monograph for over-the counter topical acne products. This amendment reclassifies the topical acne active ingredient benzoyl peroxide to a "more-data-needed" category.

NTP Information Cited
Reference to NTP Init-Prom Comparative Mouse Study using different combinations of initiators and promoters including benzoyl peroxide. (TR-441)

  • Type: Proposed Rule
  • August 07, 1991
  • 56 FR 37622
INIT/PROM